September 21 is World Alzheimer's Day, and this year's theme is "Know Thyself, Know Thyself, Prevent Early, Wisdom Early – Hand in Hand to the Future"
.
New data show that there are about 15 million dementia patients among the elderly aged 60 and over in China, of which 10 million are Alzheimer's disease patients
.
Due to the limited availability of available drugs, the majority of patients are still facing huge unmet clinical treatment needs
.
The huge patient population has brought about a huge demand
for medication.
According to public data, the global Alzheimer's disease drug market size reached 23 billion yuan in 2020 and is expected to reach 25.
7 billion yuan in 2026, with a compound annual growth rate of 1.
5%.
In China, the market size of Alzheimer's disease drugs will reach 100 billion yuan
.
In the face of this difficult but huge space market, including Eli Lilly, Johnson & Johnson, Roche, AbbVie, Merck, as well as a large number of domestic and foreign pharmaceutical companies such as Green Valley Pharmaceutical, Dongguang Pharmaceutical, Haizheng Pharmaceutical, Tonghua Jinma and so on, have risen to the challenge and actively laid out
.
At present, there are few drugs for Alzheimer's disease that have been marketed, and most of them are mainly
to improve clinical symptoms.
Among them, Aducanumab, jointly developed by Bojian and Eisaise, was approved for listing
by the FDA fast approval channel in 2021.
In November 2019, China ushered in the conditional approval of Green Valley Pharmaceutical Ganlute Sodium Capsules (GV-971, trade name: Phase 9 I), which is the original innovative drug for the treatment of Alzheimer's disease in China and was included in medical insurance
in December 2021.
However, there has been some controversy
over the above drugs since they were launched.
On April 22, 2022, Bojian announced its decision to withdraw its application for
the listing of Aduhelm (the trade name of Aducarnimumab) in Europe.
In May 2022, Green Valley Pharmaceutical also announced that it had decided to terminate the Phase 9 Phase 1 International Multicenter Phase 3 clinical study
early.
The company said it will concentrate its resources on doing a good job in the existing market, and adhere to the international listing registration goal of the drug, and restart international clinical research
when conditions permit in the future.
The industry pointed out that the research and development of Alzheimer's disease treatment drugs is difficult, the research and development cost is high, and the risk of failure is also very large
.
Previously, there have been many pharmaceutical companies to develop products folded
.
For example, on June 16 this year, Roche and the Banner Alzheimer's Institute jointly announced that crenezumab (crenezumab) did not reach the main research endpoint
in the Phase II clinical program of the Alzheimer's Disease Prevention Initiative (API) project.
This means that the new drug for AD has failed to develop
.
In addition, Johnson & Johnson, Pfizer, Lilly and other pharmaceutical companies have also folded here
.
Studies have reported that between 1998 and 2017, attempts to develop drugs to treat and prevent Alzheimer's disease failed about 146 times, and only 4 new drugs were approved to treat the symptoms
of the disease.
From the data, it can be seen that the successful development of drugs for the treatment of Alzheimer's disease is not an easy task
.
Some entrants do not intend to give up
.
For example, Eli Lilly's donanemab has completed its listing application
in the United States.
The drug becomes one of
the most anticipated to be on the market in 2022.
Evaluate Vantage expects sales of the drug to reach $6 billion
in 2026.
In China, on April 8 this year, the clinical trial application for the drug declared in China has been accepted
.
In addition, many local pharmaceutical companies are also actively deploying
.
Among them, Tonghua Jinma's class 1.
1 new drug succina octahydroampicridine tablets are in the forefront of research and development progress in domestic new drugs, and have entered phase III clinical trials
in 2017.
The 2022 semi-annual report shows that the pharmaceutical research of the phase III clinical trial of the product has ended, the pharmaceutical data has been completed, and the clinical blinding statistics
are near.
In addition to Tonghua Jinma, there are also a large number of pharmaceutical companies in China, such as Dongguang Medicine, Haizheng Pharmaceutical, and Hengrui Pharmaceutical, which are carrying out research and development
of AD new drugs or generic drugs.
According to the wisdom bud global new drug database, as of September 21, there are 627 drugs in the world containing Alzheimer's disease indications developed, of which 249 are pre-clinical, and only 48 have entered the phase III clinical trial, and 4 are applying for marketing
.
With the unremitting efforts of pharmaceutical companies, more and more courageous, I believe that one day in the future there will be an effective drug to treat Alzheimer's disease, bringing hope
to the majority of patients' families.
